submission to health authorities. - Assure and maintain regulatory device product and facility registrations, listings, license renewals and annual registrations. - Support registration into emerging markets. - Liaison with health authorities during inspections, prepare pre-inspection documentation, and
- Minimum bachelor degree in life science related field, - Minimum of 3 years of experience in the medical affairs in the pharmaceutical industry, - Experience and knowledge in the pharmaceutical industry, preferably in Regulatory Affairs (CMC) - Excellent communication and writing skills in
during the introduction of a product - Maintain the life cycle management of the clients existing products - Create and manage product information/labelling text for templates - Develop project requirement specifications and manage all aspects of the project work - Maintaining regulatory files and
extension files. Follow up with the US State health authorities for a smooth continuation of the lab licenses. • Perform copy review of promotional and scientific material to verify compliance with the approved claims. • Evaluate regulatory impact of product changes. • Support the EU Authorized
ROLE DESCRIPTION The purpose of the Quality & Regulatory Affairs Manager expert in Medical Devices will be: Develop, implement and maintain the corporate Quality strategy. Provide leadership and technical expertise to ensure regulatory compliance, continuous improvement and a high
promotion there is a permanent opening that needs to cover temporarily by a Quality & Regulatory Affairs Manager Consultant. - Duration: 4 months (approx.) - Start immediately Purpose of the job Develop, implement and maintain the corporate Quality strategy. Provide leadership and technical expertise
on current regulatory intelligence. - Manage the coordination, preparation and timely submission of regulatory documents. - Maintain current knowledge of regulations and guidelines (FDA, EMA, ICH, PMDA and others as required). - Serve as a principal interface with reviewers from FDA and other health
variations packages o Creation of the product information texts and keeping them up to date o Preparation of the responses to deficiency letters raised by regulatory authorities o Compilation of the regulatory documents in eCTD or Nees - Submitting the registration dossiers, responses, renewals and
to date • Preparation of the responses to deficiency letters raised by regulatory authorities • Compilation of the regulatory documents in eCTD or Nees 2) Submitting the registration dossiers, responses, renewals and variation packages in compliance with the strict deadlines 3) Coordinating the
Analyze and monitor external regulatory environment, including guidance and regulations from regulatory authorities; - Up to date knowledge of regulation and trends to determine and supply for guidance as needed; - Generate a good understanding of the regulatory compliance REQUIREMENTS
submission and approval documents - Documenting import, handling and approval - Assist in developing draft labeling for the company products - Be up-to-date with the regulatory guidelines to maintain Regulatory Affairs department files and be compliant REQUIREMENTS ...
Excellent knowledge of European regulatory legislation - Strong leadership skills, strategical reasoning skills and being able to critically evaluate risks - Experience with orphan dugs is preferable - Ability to prioritise between multiple tasks in a fast pace environment Are you
developing draft labeling for the company products - Be up-to-date with the regulatory guidelines to maintain Regulatory Affairs department files and be compliant REQUIREMENTS - Academic degree in life science - Experience in the pharmaceutical industry - Excellent
a regulatory affairs consultant you will be responsible for the coordination and execution of regulatory submissions in compliance with regulatory requirements. RESPONSIBILITIES - Guarantee regulatory submissions - Contribute to and implement the filing plan - Review
ROLE DESCRIPTION For a project of 6 months, you as a senior regulatory affairs officer will be involved in the preparation of regulatory submission and ensure that these are followed up and are updated in the system. RESPONSIBILITIES ...
authorities REQUIREMENTS - Academic degree in scientific or business related discipline; - Extensive experience in the pharmaceutical and/or biotech industry - 2 or more years related in a pharmaceutical / biotechnological related industry in area of regulatory
clients healthcare products - Timely preparation and approval of country records and related attachments on behalf of the representative - Be responsible for mapping all relevant submission and approval documents - Be up-to-date with the regulatory guidelines to maintain Regulatory Affairs department
vereist inzake gegevens van klanten. Fysieke aspecten: Werkt op kantoor en ook in magazijn of productie. REQUIREMENTS De medewerker Regulatory Affairs heeft kennis van en inzicht in de van toepassing zijnde nationale en internationale regelgeving en is accuraat ...